An insulin pump is a fluid infusion device for delivering insulin to people who suffer from diabetes. The pump, which is worn by the user and eliminates the need for multiple daily insulin injections, closely imitates a normally functioning pancreas by releasing hundreds of small doses of insulin each day into the body through an infusion set to regulate blood glucose levels. The rate of delivery of these small doses (i.e., the basal rate) varies from user to user. Indeed, even for a particular user, the basal rate varies throughout the day, and depends upon a variety of factors such as the user's internal clock, metabolism, physical health, and level of stress and exercise.
A basal rate profile consists of one or more basal rates defined to cover the 24 hours of the day (e.g., 24 hourly basal rates). Many users use different basal rate profiles for different circumstances. For example, one basal rate profile may be used for weekdays, another profile (i.e., with different hourly basal rates) for weekends, and another profile for vacation days. These different basal rate profiles are designed to accommodate the expected differences in the user's background insulin needs resulting from variations in the user's sleep patterns, levels of exercise and stress, health condition, menstrual cycle status, etc. during such periods.
As the amount and rate of insulin delivery (both basal and bolus) must be tailored to the individual needs of the user, modern pumps are programmable. Some pumps are capable of communicating with a separate computing device, and are compatible with software applications that may be executed on the computing device. The software permits an operator, such as the user or a health care provider, to customize the settings of the various parameters that affect the pump's operation. In particular, it is commonly necessary to make adjustments to the basal rate profiles stored in a user's pump. As multiple profiles (i.e., profile sets) are typically stored in a pump as mentioned above, the operator may need to review the data for each of the profiles to decide which profile(s) require modification. Sometimes a single profile requires modification. Other times, entire profile sets require modification. To determine which profiles must be changed on a user's pump, the operator using conventional programming software activates each profile by accessing the file containing the underlying basal rate profile data, and views the data in a tabular or graphical format.
The above-mentioned profile modifications may be accomplished by replacing a profile or set of profiles existing on a pump with profiles (or edited versions of profiles) existing in source files stored on the computing device. An operator, such as a health care provider, may use a computing device that stores many such source files. Accordingly, the operator using conventional programming software must continue to access the various source files to view the underlying data until the operator identifies a source file containing the desired profile. The operator then either edits the profile before using it as a replacement for an existing pump profile, or saves the unedited profile directly to the pump.
In the process of replacing or editing a pump profile, the operator must take care in avoiding any inadvertent changes as unintentional modifications to insulin delivery parameters may directly affect the health of the user. Under delivery of insulin may result in hyperglycemia (high blood glucose levels), which may increase the risk of infection and, if persistent for long periods, may cause damage to the retinas and kidneys, and nerve damage. Over delivery of insulin may immediately lead to hypoglycemia, which may result in seizures, unconsciousness, and other highly undesirable manifestations of low blood glucose levels. Accordingly, conventional programming software incorporates safety features that prompt the operator to review the proposed modifications to pump profiles before the pump is programmed.
As illustrated by the above-described characteristics, insulin pump basal rate profile programming may be a relatively time-consuming, complicated, and error-prone task which, if performed incorrectly, may lead to serious health risks for the pump user. Accordingly, pump programming software should be designed to simplify, to the extent possible, the programming processes while simultaneously incorporating safety measures to prevent operators from inadvertently programming a pump with parameter settings that may harm the user or adversely affect the operation of the pump. Features that facilitate simple, safe pump programming are particularly helpful to health care providers who may be responsible for programming multiple pumps on a regular basis.